Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.
FDA Recall Z-0107-2015 · Posted 2014-10-21
Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-07-31
Date Terminated2017-04-20
Product Quantity2,247 units
Reason for Recall
Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.
Firm Action
Mindray DS USA, Inc. sent a Recall Correction Action Letter to their customers via certified mail with return receipt on July 31, 2014.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.